Senior Manager - 1

SUN PHARMA


Date: 1 week ago
City: Vadodara, Gujarat
Contract type: Full time
  • Characterization of RLD pack samples.
  • Finalization of packing configuration for Exhibit batch packing of new generic product/NDA as per requirement.
  • Identification of new packaging material & new vendor development for packaging materials.
  • Mold development for primary packaging material & secondary packaging material & its validation.
  • Support to Regulatory team on ANDA’s/NDA’s filling for regulated market.
  • Coordination with NPI & planning team for launch of ANDA’s/NDA’s.
  • Preparation & revision of packaging material specification.
  • Preparation & review of MPC, FMEA, TA, DHF & AFMEA.
  • Preparation & review of Development Study protocol & report & execute the study.
  • Performing functional test as per regulatory requirement.
  • Coordination with Cross functional team like (FDD/RA/Plant/Marketing/PMO) for completion of task.
  • Participating in FAT of machines.
  • Support to plant for validation, trouble shooting and market complaints.
  • SOP preparation, periodic review and packaging lab equipment handling/maintain calibration records.
  • Preparation of Packaging documentation (Pack Style, Justification Report etc. as per Product/Regulatory) as required.
  • Handling of primary and secondary packaging material in storage area & maintaining the PM quantity for stability packaging at R&D.

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